FORSTAVIR-EM - Emtricitabine 200 mg and Tenofovir Disoproxil Fumarate 300 mg Tablets

Country: মাল্যাশিয়া

ভাষা: ইংরেজি

সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

সক্রিয় উপাদান:

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

থেকে পাওয়া:

UNIMED SDN BHD

INN (International Name):

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

প্যাকেজ ইউনিট:

30 Tablets

Manufactured by:

Aurobindo Pharma Limited (Unit III),

তথ্য লিফলেট

CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)
FORSTAVIR-EM
Emtricitabine 200 mg dan Tenofovir Disoproxil Fumarate 300 mg Tablets
1
WHAT IS IN THIS LEAFLET
1.
What FORSTAVIR-EM is used
for
2.
How FORSTAVIR-EM works
3.
Before
you
use
FORSTAVIR-
EM.
4.
How to use FORSTAVIR-EM
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
FORSTAVIR-EM
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT FORSTAVIR-EM IS USED FOR
FORSTAVIR-EM
is
used
in
combination with other antiretroviral
drugs
for
the
treatment
of
HIV-1
infection in adults.
FORSTAVIR-EM
is
used
in
combination with safe sex practices as
pre-exposure
prophylaxis
to
reduce
the risk of sexually acquired HIV-1
infection in adults.
HOW FORSTAVIR-EM WORKS
FORSTAVIR-EM contains two active
ingredients
which
are
emtricitabine
and
tenofovir
disoproxil
fumarate.
Both of these active ingredients are
antiretrovirals
used
to
treat
HIV
infection.
Emtricitabine
is
a
nucleoside
reverse
transcriptase
inhibitor and tenofovir is a nucleotide
reverse
transcriptase
inhibitor.
However, both are generally known as
NRTIs and they work by interfering
with the normal function of an enzyme
(reverse transcriptase) that is essential
for viruses to reproduce on their own.
BEFORE YOU USE FORSTAVIR-EM
-
When you must not use it
Do not take FORSTAVIR- EM
If you are :

Allergic
to
Emtricitabine
or
Tenofovir
Disoproxil
Fumarate,
or any of the other ingredients in
FORSTAVIR-EM Tablets.

Do not take FORSTAVIR-EM if
you
are
pregnant,
planning
to
become pregnant or may become
pregnant.

Do not take FORSTAVIR-EM if
you are breast-feeding. Consult a
doctor
or
pharmacist
before
taking any medication.
-
Before
you
start
to
use
FORSTAVIR- EM tablet

Tell your doctor if you have lactic
acidosis (excess lactic acid in the
blood) or liver inflammation and
fatty liver disease.

Tell
your
doctor
if
you
have
a
combination
of
Human
Immunodeficiency Virus (HIV) -
Hepatitis B Virus (HBV) disease.
Discontinuation
of
the
drug
tenofovir
dis

পণ্য বৈশিষ্ট্য

COMPOSITION:
Each film coated tablet contains
Emtricitabine ..... ........... ......... .......... 200 mg
Tenofovir disoproxil fumarate ...... ... ... 300 mg
equivalent to Tenofovir disoproxil ........ 245 mg
DOSAGE FORM
Film coated tablet
PRODUCT DESCRIPTION
-
FORSTAVIR-EM should not be coadministered with lamivudine+tenofovir
DF+Efavirenz,emtricitabine,tenofovir
DF
or
lamivudine-containing
products [seeWARNINGS AND PRECAUTIONS ].
In treatment experienced patients, the use of FORSTAVIR-EM should be
guided by laboratory testing and treatment history.
PHARMACOLOGY
PHARMACODYNAMICS
Emtricitabine is an NRTI that is converted intracellularly to its
active
metabolite, emtricitabine 5'-triphosphate. Tenofovir DF is an ester
prodrug
of the NRTI, tenofovir. The prodrug is hydrolysed intracellularly to
tenofovir,
which is then converted to the active metabolite, tenofovir
diphosphate. The
active metabolites of the drugs compete with deoxycytidine
5'-triphosphate
(emtricitabine 5'-triphosphate) or deoxyadenosine 5'- triphosphate
(tenofovir
diphosphate) for incorporation into HIV DNA, thereby terminating viral
DNA
chain growth and inhibiting the activity of the viral reverse
transcriptase.
PHARMACOKINETICS
ABSORPTION
The median bioavailability of emtricitabine in fasted patients
following a single
oral dose is 92%. The median bioavailability of tenofovir in fasted
patients
following a single oral dose is 25%.
DISTRIBUTION
Protein binding of emtricitabine is less than 4%; and of tenofovir, is
less than
0.7% (plasma) and 7.2% (serum).
METABOLISM AND ELIMINATION
Emtricitabine undergoes limited metabolism and is primarily excreted
by
the kidneys. The median terminal elimination half-lives of
emtricitabine and
tenofovir were 15.5 and 17.6 hours.
INDICATION
TREATMENT OF HIV-1 INFECTION:
FORSTAVIR-EM is indicated in combination with other antiretroviral
agents
(such as non nucleoside reverse transcriptase inhibitors or protease
inhibitors) for the treatment of HIV-1
infection in adults.
The following points should be considered wh